Description:
This phase II trial studies how well radiation therapy works in treating post-menopausal
women with early stage breast cancer undergoing surgery. Radiation therapy uses high energy x
rays to kill tumor cells. This may be an effective treatment for breast cancer.
Title
- Brief Title: Radiation Therapy in Treating Post-Menopausal Women With Early Stage Breast Cancer Undergoing Surgery
- Official Title: Phase II Trial of Single Fraction Radiation Therapy (SFRT) at Roswell Park Cancer Institute for Select Patients With Early Stage Breast Cancer
Clinical Trial IDs
- ORG STUDY ID:
I 108907
- SECONDARY ID:
NCI-2009-01568
- SECONDARY ID:
I 108907
- SECONDARY ID:
P30CA016056
- NCT ID:
NCT01754519
Conditions
- Ductal Breast Carcinoma In Situ
- Estrogen Receptor Negative
- Estrogen Receptor Positive
- HER2/Neu Negative
- Invasive Cribriform Breast Carcinoma
- Invasive Ductal Carcinoma, Not Otherwise Specified
- Lobular Breast Carcinoma In Situ
- Mucinous Breast Carcinoma
- Papillary Breast Carcinoma
- Progesterone Receptor Positive
- Stage I Breast Cancer
- Stage II Breast Cancer
- Stage IIIA Breast Cancer
- Stage IIIC Breast Cancer
- Tubular Breast Carcinoma
Purpose
This phase II trial studies how well radiation therapy works in treating post-menopausal
women with early stage breast cancer undergoing surgery. Radiation therapy uses high energy x
rays to kill tumor cells. This may be an effective treatment for breast cancer.
Detailed Description
PRIMARY OBJECTIVE:
I. For select patients with early stage breast cancer undergoing wide local excision followed
by single fraction radiation therapy (SFRT), we will evaluate rates of observer-rated
toxicity, cosmetic outcomes and patient satisfaction, objective measures of toxicity and
quality of life as well as delivery of intended dose.
SECONDARY OBJECTIVE:
I. Locoregional control reported at five years.
OUTLINE:
Patients undergo wide local excision breast surgery and SFRT over 60-100 minutes once
negative margins are obtained.
After completion of study treatment, patients are followed at 1 week, 1 month, 3 months, and
then every 6 months for 2 years.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Treatment (radiation therapy) | Experimental | Patients undergo wide local excision breast surgery and SFRT over 60-100 minutes once negative margins are obtained. | |
Eligibility Criteria
Inclusion Criteria:
- Core needle biopsy (e.g. Mammotome, core, stereotactic, ultrasound guided) showing
invasive mammary cancer (with or without concomitant ductal carcinoma or lobular
carcinoma in situ) or ductal carcinoma in situ; acceptable histologic types of
invasive mammary cancer include ductal, tubular, mucinous, papillary, cribriform and
"NOS" (not otherwise specified); invasive lobular cancer is excluded
- Age >= 50 years and postmenopausal with no menses for at least one year prior to study
enrollment
- Age > 70 years with invasive breast cancer clinical size =< 3 cm OR Age 50 - 70 years
with invasive breast cancer clinical size =< 1.5 cm OR Age >= 50 years and
postmenopausal with any grade ductal carcinoma in situ (DCIS) clinical extent =< 1.5
cm (clinical tumor size will be determined by pre-operative breast
imaging-mammography, ultrasound and/or magnetic resonance imaging; in cases of
multiple measurements, the largest recorded single dimension will be used to determine
eligibility)
- Hormone receptor status
- Estrogen or progesterone receptor positive or
- Estrogen and progesterone receptor negative and clinical tumor size =< 1.0 cm
- Human epidermal growth factor receptor 2 (HER2)/neu negative on the core biopsy
analysis defined as 0 or 1+ by immunohistochemistry or not amplified by fluorescent in
situ hybridization analysis
- Tumor >= 0.5 cm from skin as defined by breast ultrasound
- Unicentric tumor
- Axillary lymph nodes negative by pre-operative physical examination in all cases and
pathologic examination from surgery for invasive disease
- Negative surgical margins, defined as no margin-labeling ink on tumor cells from
margin evaluation
Exclusion Criteria:
- Initial core biopsy showing invasive lobular cancer
- Estrogen receptor and progesterone receptor negative tumor with clinical size > 1 cm
- Any Her 2+ breast cancer (immunohistochemistry 3+; or amplified by fluorescence in
situ hybridization [FISH])
- Cancer in a patient with a known inherited susceptibility mutation in breast cancer
(BRCA)1 or BRCA2
- Multicentric breast cancer (two foci of known cancer in the breast separated by
greater than 5 cm, or in separate quadrants
- Clinically or pathologically positive axillary lymph nodes
- Any prior breast cancer
- Prior breast radiation therapy
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 50 Years |
| Eligible Gender: | Female |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Number of Patients With Adverse Events as a Measure of Safety and Tolerability |
| Time Frame: | Up to 2 years |
| Safety Issue: | |
| Description: | Toxicity will be assessed by the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) v 3.0. |
Secondary Outcome Measures
| Measure: | Locoregional Control Rate |
| Time Frame: | At 5 years |
| Safety Issue: | |
| Description: | Locoregional control will be calculated with confidence interval estimates and will be compared to historical control rates. |
| Measure: | Overall Survival |
| Time Frame: | Up to 5 years |
| Safety Issue: | |
| Description: | The overall survival will be analyzed using Kaplan-Meier method. |
| Measure: | Disease Specific Survival |
| Time Frame: | Up to 5 years |
| Safety Issue: | |
| Description: | The disease specific survival will be analyzed using Kaplan-Meier method. |
Details
| Phase: | Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Terminated |
| Lead Sponsor: | Roswell Park Cancer Institute |
Last Updated
July 7, 2017
